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Investigational Device Exemption #

Swedish translation: IDE nr.

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)

English term or phrase:	Investigational Device Exemption #
Swedish translation:	IDE nr.
Entered by:	Sven Petersson

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11:05 Jun 12, 2004

English to Swedish translations [PRO]
Medical - Medical: Cardiology

English term or phrase: Investigational Device Exemption #

Source language: American English

Abbreviation: IDE #

Sven Petersson KudoZ activity Questions: 735 (none open) (15 without valid answers) (10 closed without grading) Answers: 14215 Sweden
Local time: 20:18

investigational device exemption (IDE)

Explanation:
har jag ännu inte sett på svenska annat än oöversatt;
kallas ibland Ausnahmegenehmigung på tyska

"IDE Overview
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to FDA. Clinical studies are most often conducted to support a PMA"
http://www.fda.gov/cdrh/devadvice/ide/index.shtml